Freedom of Information request on the authorisation of Monkeypox Vaccine Imvanex (FOI22/803)
Published 21 December 2023
FOI 22/803
18th July 2022
Dear
Thank you for your email.
Imvanex is not currently authorised for use specifically for prevention on monkeypox. However, it is authorised for the prevention of smallpox, which is a related virus to monkeypox. Further information is provided by the UK Health Security Agency and in the Green Book Chapter 29, both of which are linked below:
https://www.gov.uk/government/publications/smallpox-and-vaccinia-the-green-book-chapter-29
Information on the effectiveness of Imvanex against smallpox is provided in the PAR published by the EMA, a link to this is provided below:
https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex
The Imvanex vaccine is know as Jynneos in the US and the FDA have approved the vaccine for both smallpox and monkeypox infection:
https://www.fda.gov/vaccines-blood-biologics/jynneos
https://www.fda.gov/media/131802/download
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre